Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01768624




Registration number
NCT01768624
Ethics application status
Date submitted
11/01/2013
Date registered
15/01/2013
Date last updated
26/10/2016

Titles & IDs
Public title
PINOT Follow-up Study in End-stage Kidney Disease
Scientific title
Patient Information About Options for Treatment (PINOT) Follow up Study: Answering Important Questions in Home Dialysis and Conservative Care.
Secondary ID [1] 0 0
RM-1/12
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Stage 5 chronic kidney disease - Patients receiving home hemodialysis Patients receiving home peritoneal dialysis Patients receiving center-based hemodialysis Patients who had a pre-emptive kidney transplant Patients who planned for renal conservative care
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The proportion of patients who make the transition to home dialysis, after an initial start on center-based hemodialysis.
Timepoint [1] 0 0
5 years
Secondary outcome [1] 0 0
The proportion of patients who commence dialysis, or have a time-limited trial of dialysis within 3 and 5 years, after a confirmed plan for conservative care.
Timepoint [1] 0 0
5 years

Eligibility
Key inclusion criteria
* Adults and children with end stage kidney disease (eGFR <15 ml/min) who commenced renal replacement therapy or conservative care in Australia between July and September 2009
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients returning to dialysis after a failed transplant,
* Patients with acute renal failure

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2016
Sample size
Target
Accrual to date
Final
721
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
University of Sydney - Sydney
Recruitment postcode(s) [1] 0 0
2006 - Sydney
Recruitment outside Australia
Country [1] 0 0
United Kingdom
State/province [1] 0 0
Oxfordshire

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
Sydney South West Area Health Service
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
South West Sydney Local Health District
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Kidney Health Australia
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Rachael L Morton, PhD
Address 0 0
University of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Morton RL, Webster AC, McGeechan K, Howard K, Murt... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT01768624